Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis

Phase 3

Completed

• Conditions: Adult Periodontitis
• Interventions: Procedure: Scaling and root planing; Drug: minocycline HCl 2.1%

• Registration Number: NCT00529555
• Lead Sponsor: Sunstar Americas

Brief Summary

Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-14
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2013-07-10
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-10
• Last Update Submitted: 2014-04-10
• Results First Posted: 2014-05-09
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

Inclusion Criteria

• moderate to severe periodontitis

Exclusion Criteria

• recent periodontal therapy
• certain medical or dental conditions
• pregnancy
• allergy to active drug or related drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and root planing + SHAM TX	Scaling and root planing	sham treatment
Scaling and root planing + Vehicle	Scaling and root planing	Placebo
Scaling & root planing + Periocline Gel	minocycline HCl 2.1%	Minocycline HCL 2.1%

Primary Outcome Measures

Name	Time	Method
Change in Pocket Depth.	baseline & 9 months	Average change of Pocket Depth at 9 months from baseline

Trial Locations

Locations (10)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California - San Francisco; 🇺🇸 San Francisco, California, United States

University of Michigan Oral Health Research Center; 🇺🇸 Ann Arbor, Michigan, United States

University of Florida; 🇺🇸 Gainsville, Florida, United States

University of Maryland - Dental School; 🇺🇸 Baltimore, Maryland, United States

Boston University Dental School; 🇺🇸 Boston, Massachusetts, United States

University of Pennsylvania Dental School; 🇺🇸 Philadelphia, Pennsylvania, United States

State University of New York at Buffalo, Dental Medicine; 🇺🇸 Buffalo, New York, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States